Process Controls Engineer Biopharma

TekWissen • Portsmouth, NH

3d • Onsite

About The Position

This is a Technical engineering role providing support to pharmaceutical/biotechnology manufacturing operations, with a primary focus on manufacturing and process automation systems, instrumentation, and equipment. Serves as a technical resource to Operations and supports troubleshooting, technical analysis, technology transfers, projects, process improvements, quality issues, change controls, and lot-release activities. Works closely with Manufacturing, Engineering, and Quality Assurance teams to maintain reliable manufacturing operations and compliance with cGMP, safety, and site requirements.

Requirements

• Bachelor’s degree in an applicable Engineering field or Computer Science.
• 5–10 years of experience in pharmaceutical, biotechnology, or equivalent industrial automation environments.
• Advanced experience with manufacturing and process automation systems.
• Strong knowledge of instrumentation and automation systems.
• Hands-on experience troubleshooting manufacturing equipment and automation/control systems.
• Experience with PI data analysis.
• Ability to review and troubleshoot automation/control system code.
• Knowledge of pharmaceutical or biotechnology manufacturing processes.
• Working knowledge of cGMP requirements and pharmaceutical quality standards.
• Experience with change control and lot-release processes.
• Ability to interpret and work with SOPs, Functional Specifications, and Work Instructions.
• Strong critical-thinking, logical problem-solving, analytical, and technical troubleshooting skills.
• Experience supporting continuous improvement, technology transfer, and automation projects.
• Proficiency with Microsoft Office Suite, particularly Outlook, Word, and Excel.
• Strong communication and collaboration skills.
• Ability to work effectively with Manufacturing, Engineering, and Quality Assurance teams.
• Ability to work independently under general supervision.
• Ability to establish appropriate methods and procedures for achieving technical objectives.
• Business-fluent English communication skills.
• Knowledge of safety procedures and ability to identify potential manufacturing safety hazards.
• Ability to work effectively in a regulated pharmaceutical/biotechnology manufacturing environment.
• Willingness and ability to participate in on-call support when required.

Responsibilities

• Provide technical support to manufacturing operations related to process automation systems, instrumentation, and equipment.
• Troubleshoot manufacturing equipment, automation systems, and control systems to support production requirements.
• Develop and maintain strong technical knowledge of manufacturing equipment and process automation systems.
• Support technology transfers, automation projects, process improvements, and other technical initiatives.
• Assist with the resolution of equipment breakdowns, manufacturing issues, and quality issues.
• Perform technical analyses, including PI data analysis, to support manufacturing troubleshooting and process improvements.
• Review and troubleshoot automation/control system code.
• Provide technical support during normal business hours and participate in an on-call rotation when required.
• Participate in IPT/JPT meetings and other cross-functional meetings as the Controls representative.
• Initiate and participate in all aspects of the change control process.
• Complete change request lot assessments to support lot-release activities.
• Review SOPs, Functional Specifications, and Work Instructions.
• Support manufacturing troubleshooting while identifying potential safety hazards and kinetic energy sources.
• Ensure adherence to cGMP requirements during API manufacturing activities.
• Report regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions to responsible management.
• Collaborate closely with Manufacturing, Engineering, and Quality Assurance teams.
• Maintain compliance with assigned training requirements and applicable site procedures.
• Follow all applicable safety procedures and promote a strong safety culture.
• Perform other duties as assigned.

What This Job Offers

• Career Level: Mid Level